Early Albumin Resuscitation During Septic Shock

Septic Shock Clinical Trial

Official title:

Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327704
• Other study ID #: LFB N°ALBU-0503
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2006
• Last updated: April 5, 2011
• Start date: July 2006
• Est. completion date: January 2011

Study information

• Verified date: April 2011
• Source: Laboratoire français de Fractionnement et de Biotechnologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Objective: To determine whether the early administration of albumin as an expander and antioxidant would improve survival on the 28th day for septic shock patients.

Design: Prospective, multicenter, randomized, controlled versus saline, stratified on nosocomial infection and center.

Setting: 27 Intensive Care Units (ICU) in France

Coordinator: Pr J.P. Mira and Dr J. Charpentier - Cochin Hospital- Paris

Patients: 800 patients could be included during the first 6 hours of their septic shock.

Description:

The primary outcome: Mortality during the 28 day period after randomization. The secondary outcomes: Evaluation of SOFA score, ventilator-free days, dialysis free days, catecholamine free days, days of hospitalisation, incidence of nosocomial infections.

The albuminemia of all patients is requested before the treatment until Day 4 post treatment.

The treatment is: Vialebex 20% 100ml every 8 hours during 3 days versus saline 100ml every 8 hours during 3 days.

The first patient will be in July 2006, the last patient expected is on July 2009.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 794
• Est. completion date: January 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Over 18 years old

• Septic shock < 6 hours

• Agreement of patients

Exclusion Criteria:

• Allergy to albumin

• Weight > 120 kg

• Non septic shock

• Burned

• Cirrhosis

• Albumin perfusion 48 hours before randomization

• Pregnant women

• Cardiac dysfunction New York Heart Association (NYHA) 3 or 4

• Patients with therapeutic limitation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• albumin
albumin 20% 100 ml/8 hours for 3 days
• saline
saline 100 ml/8hours for 3 days

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoire français de Fractionnement et de Biotechnologies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality, any cause, during the 28 day period after randomization		day 28	No
Secondary	Evaluation of sequential organ failure assessment (SOFA) score		ICU period	No
Secondary	catecholamine free days		day 28	No
Secondary	incidence of nosocomial infection		ICU period	No
Secondary	mortality at 90 days		day 90	No
Secondary	length of ICU hospitalisation		ICU discharge	No
Secondary	length of total hospitalisation		hospital discharge	No